K220838 is an FDA 510(k) clearance for the Artisan Bone Plug, Universal Cement Restrictor. This device is classified as a Cement Obturator (Class II — Special Controls, product code LZN).
Submitted by Howmedica Osteonics, Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on May 20, 2022, 59 days after receiving the submission on March 22, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K220838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2022 |
| Decision Date | May 20, 2022 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZN — Cement Obturator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |